October 19, 2018 at 5:00 am ET
With controversy over its safety raging for more than a decade, you’ve almost certainly heard about bisphenol A.
In response to the controversy, legislative bans have been proposed over the years in Congress, state legislatures and even a few local counties. The concern stems from an allegation from some scientists who asserted that BPA could be “hormone disrupting” at very low levels of exposure.
So it gave many pause, considering that we may be exposed to trace levels of BPA from common consumer products. The public needed to know: Are the claims true?
Given its mission to protect public health and its regulatory oversight of foods and food-contact materials, the Food and Drug Administration has been engaged on the issue of BPA safety for many years. Most recently, the FDA worked with the Department of Health and Human Services’ National Toxicology Program and National Institute of Environmental Health Sciences to design and conduct a multiyear, multimillion dollar study known as CLARITY.
The scope and magnitude of the study are unprecedented for BPA. The key part of the study, the so-called Core Study, was conducted by senior scientists at the FDA’s National Center for Toxicological Research in Arkansas. The final report, released on Sept. 28, found that BPA has very little potential to cause health effects, even after a lifetime of low-level exposure.
In the words of the study’s principal investigator: “In the study author’s judgment of the results … BPA did not elicit clear, biologically plausible, adverse effects …” at levels even remotely close to typical consumer exposure levels. Importantly, the report was peer-reviewed before finalization by a panel of independent scientists who endorsed the design and conduct of the study as well as the FDA’s interpretation of the results.
The CLARITY study is the capstone of a nearly 10-year effort designed to resolve uncertainties about the safety of BPA. Earlier studies conducted at NCTR found that BPA is rapidly eliminated from the body and therefore unlikely to cause health effects at the very low levels to which people are typically exposed. The CLARITY Core Study confirms that prediction.
Also included in the CLARITY study is a component involving additional research by a group of academic scientists, many of whom have been critics of BPA. Many of them have not published their findings, although all of their raw data has now been released by NTP for others to analyze.
The naysayers may never stop saying nay, but the results from the complete set of studies conducted by the FDA’s experts are compelling. Indeed, the FDA has met its goal to resolve uncertainties about the safety of BPA, and it’s no wonder that the FDA answers the question “Is BPA safe?” with the straightforward answer — “Yes.”
Was it worth $30 million of taxpayer money to get clarity on the safety of BPA? In comparison to the much-larger amount of money spent on studies that generated the controversy in the first place, much of that from federally funded grants, the CLARITY price tag is a bargain. But now it’s time to redirect those grants to more pressing topics.
Dr. Steven G. Hentges leads the Polycarbonate/BPA Global Group of the American Chemistry Council and has been deeply involved with the science on bisphenol A for more than 16 years.
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